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ACLU Sues To Challenge FDA Limits On Access To Abortion Pill

(AP) — The American Civil Liberties Union filed a lawsuit Tuesday on behalf of a Kauai doctor to challenge federal restrictions that prevent women from filling a prescription for the so-called abortion pill at commercial pharmacies.

The lawsuit, filed in U.S. District Court in Honolulu, targets long-standing restrictions imposed by the U.S. Food and Drug Administration that ACLU says “significantly limits” women’s access to the pill, which is marketed in the U.S. as Mifeprex and used for abortions up to 10 weeks of pregnancy.

Under the FDA restrictions, which has been in place since 2000, the pill can be dispensed only in clinics, hospitals and doctors’ offices with a prescription from a doctor who is on a list of certified abortion providers.

Dr. Graham Chelius, a Kauai doctor, is seeking to overturn federal restrictions in order to prescribe the so-called abortion pill and let his patients pick it up from a local pharmacy.

Courtesy of Graham Chelius

Dr. Graham Chelius, the lead plaintiff who has practiced family medicine in Kauai since 2009, says he is qualified to provide the pill to his patients but is unable to stock it at the hospital where he works because of objections from some colleagues.

As a result, Chelius says, his patients must carry an unwanted pregnancy to term or fly to another island to get an abortion — boosting costs and sometimes delaying the procedure by several weeks.

This could be avoided if the pill were available at pharmacies on Kauai, which has no abortion providers.

“The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?” said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project. “The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

The FDA issued new guidelines for the use of Mifeprex last year, saying at the time that its restrictions continue to be necessary to ensure safe use of the drug.

The FDA confirmed this week that the agency’s position has not changed since then. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.

According to a commentary earlier this year in the New England Journal of Medicine, 19 deaths have been reported to the FDA among the more than 3 million women who have used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.

“The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?” — Julia Kaye, an attorney with the ACLU Reproductive Freedom Project.

The commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office.

Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, said the 10 co-authors, who included doctors and academics from Stanford, Princeton and Columbia universities.

According to the latest federal figures, medical abortions — generally a two-pill regimen using Mifeprex and the drug misoprostol — accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.

Women using the pill generally take it in the privacy of their home. Noting that, Kaye said the legal case “is primarily about where a woman must be standing when she’s handed the abortion pill that’s been prescribed to her.”

“The FDA restriction defies common sense,” Kaye said. “There’s no medical issue in whether she’s handed the pill at a pharmacy or at a clinic.”

There is precedent for a federal court to overturn FDA restrictions. In 2013, a federal judge in New York ordered that the most common version of the morning-after pill must be accessible over-the-counter for all customers of all ages, instead of requiring a prescription for girls 16 and younger.

The ACLU also argues that the federal restrictions on Mifeprex violates a 2016 U.S. Supreme Court decision, Whole Woman’s Health v. Hellerstedt, which emphasized that no “undue burden” can be placed upon women’s access to abortion.

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